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IRCT20220509054799N1 IRCT 2022-06-06 Iran University of Medical Sciences Comparison of the effect of vitamin D and vitamin C cream and their composition on pregnancy striae in first pregnant women Comparison of the effect of vitamin D and vitamin C cream and their composition on pregnancy striae in first pregnant women 2022-05-22 anticipated 120 Complete https://irct.ir/trial/63429 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Before starting the study, a hypothetical list of 120 pieces was prepared and through the random block method by seal envelope site by specifying the number of blocks of 8 and 16, for participants in four groups of 30 worms A and worm B And worm C and worm D will be created. Numbered, matte and sealed envelopes will be used to hide the allocation and protect the blind. The envelopes will be opened in the order in which the participants enter the study. Eventually, 30 people will enter each group. One group will be given cream with code A, another group with cream with code B, another group with cream with code C and another group with cream with code D. These creams will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. Since this study is a three-blind clinical trial, the worms will be identified by codes A, B, C and D, and the type of worms will not be identified, Blinding description: Numbered, matte and sealed envelopes will be used to hide the allocation and protect the blind. The envelopes will be opened in the order in which the participants enter the study. Eventually, 30 people will enter each group. One group of worms with code A will be given another group of worms with code B, another group with worms with code C and another group with worms with code D, thus blinding the participants. These creams will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. Since this study is a three-blind clinical trial, in order to keep the researcher and analyzer of the worms blind, the codes A, B, C and D will be specified and the type of worms will not be specified. 3 Pregnancy striae. Intervention 1: Intervention group: Consumer of vitamin D - Participants receive topical vitamin D 5000 units per 100 grams of uranda base cream (containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water) for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Intervention 2: Intervention group: Consumer of vitamin C - Participants receive 3% topical vitamin C in 100 g of uranda base cream (containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water) for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Intervention 3: Intervention group: Consumer of Vitamin C + D - Participants of topical vitamin D 5000 units in 100 g of Orande base cream (containing alcohol, glycerin, triethanolamine, monostaric acid, white Vaseline and distilled water) with topical vitamin C 3%, Receive for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Intervention 4: Control group: Base Cream Consumer - Participants receive Eurend Base Cream containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months, daily, twice a day for 12 hours using a finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to the cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Dr. Masoumeh Kheirkhah
Vali Asr Street, above Vanak Square, Rashid Yasemi Street Iranian School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1000 kheirkhah.m@iums.ac.ir Iran University of Medical Sciences scientific Dr. Masoumeh Kheirkhah
Vali Asr Street, above Vanak Square, Rashid Yasemi Street Iranian School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1000 kheirkhah.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Primigravid healthy pregnant women The age group of 20-40 years, 18-20 weeks pregnancy Body mass index 18.5-25 Have a minimum literacy 20 years 40 years Female Known systemic or underlying disease (such as gestational diabetes, preeclampsia, adrenal insufficiency, and Cushing's disease) Multiple pregnancies History of pre-striae skin diseases History of allergies to vitamin D and C. Maternal polyhydramnios Diagnosis of macrosomic embryos Prevention Prevention Prevention Placebo Intervention group: Consumer of vitamin D - Participants receive topical vitamin D 5000 units per 100 grams of uranda base cream (containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water) for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Intervention group: Consumer of vitamin C - Participants receive 3% topical vitamin C in 100 g of uranda base cream (containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water) for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Intervention group: Consumer of Vitamin C + D - Participants of topical vitamin D 5000 units in 100 g of Orande base cream (containing alcohol, glycerin, triethanolamine, monostaric acid, white Vaseline and distilled water) with topical vitamin C 3%, Receive for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months daily, twice a day every 12 hours using the finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Control group: Base Cream Consumer - Participants receive Eurend Base Cream containing alcohol, glycerin, triethanolamine, mono-stearic acid, white Vaseline and distilled water for 4 months. This cream will be prepared by the order of the researcher and by a pharmaceutical consultant in the School of Traditional Medicine of Iran. How to use it is that this cream for 4 months, daily, twice a day for 12 hours using a finger, topically and gently and without massaging the skin of the abdomen, thighs, breasts and buttocks to the cover Apply all those areas with a thin layer of cream and people are asked not to wash it after use until it is absorbed. Striae are skin changes that occur in situations where the skin is under the physical pull of sudden growth during adolescence, pregnancy, or in conditions such as Cushing's syndrome, in which severe hormonal changes occur in the body. In mid-pregnancy, reddish, slightly sunken streaks usually form on the skin of the abdomen and sometimes on the skin above the breasts and thighs. These are called stria gravidarum or stretch marks. These lines lose their pigmentation some time after delivery, turn oyster white, and eventually remain atrophic, slightly wrinkled, and sunken over time. Timepoint: Before, 4, 8, 12 and 16 weeks after the start of the intervention. Method of measurement: In this study, the practical definition is in accordance with the above theoretical definition and the Atwal scale is used to measure this variable. This scale is used to classify women based on the severity of striae. Based on this system, the abdomen, breast, thighs and buttocks are examined for the severity of erythema and the number of stretch marks. The maximum score in each area is 6. The total score is 0-3 without striae or without significant striae, the total score is 4-9 mild striae, the total score is 10-15 moderate striae and the total score is more than 16 is severe striae. Iran University of Medical Sciences Approved 2022-06-01 Ethics Committee of Iran University of Medical Sciences Hemmat Highway between Chamran and Sheikh Fazlollah Iran University of Medical Sciences Headquarters Fifth Floor Tehran Tehran Iran (Islamic Republic of)