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CTRI Number  CTRI/2024/12/077657 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see the effect of an Ayurvedic medicine in the management of constipation during pregnancy 
Scientific Title of Study   A randomized open labelled controlled clinical study to evaluate the efficacy of Haritakyadi Yoga in the management of Garbhini vibandha W.S.R constipation during pregnancy. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monika 
Designation  MS Scholar Prasuti Tantra Evam Stree Roga 
Affiliation  Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 
Address  Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118

Kurukshetra
HARYANA
136118
India 
Phone  9896929060  
Fax    
Email  drmonikayadav09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitesh Kumar Panda 
Designation  Professor and H.O.D , Department or Prasuti Tantra Evam Stree Roga 
Affiliation  Institute for Ayurved Studies and Research Umri road sector 08 kurukshetra Haryana 136118 
Address  Room no 112 PG Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118

Kurukshetra
HARYANA
136118
India 
Phone  9896033056  
Fax    
Email  drjk67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monika 
Designation  MS Scholar Prasuti Tantra Evam Stree Roga 
Affiliation  Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 
Address  Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118

Kurukshetra
HARYANA
136118
India 
Phone  9896929060  
Fax    
Email  drmonikayadav09@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studied and Research Umri road sector 08 Kurukshetra Haryana 136118 
 
Primary Sponsor  
Name  Dr Monika 
Address  Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monika  Institute For Ayurved Studies and Research, umri road sector 08, Kurukshetra, Haryana.  Room no 15, Department of Prasuti Tantra Evam Stree Roga.
Kurukshetra
HARYANA 
9896929060

drmonikayadav09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna Ayush University Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Haritakyadi Yoga, Reference: Harita Samhita tritya sthan 51/10, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: patient can add guda according to her taste
2Comparator Arm (Non Ayurveda)-syrup Lactulosepatient will take 15 ml of syrup lactulose with plenty of water twice a day after meal for 7 days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Patients having confirm diagnosis of pregnancy.
2 Patients presenting the classical symptoms of Garbhini
Vibandha.
3 All patient diagnosed with Vibandha during 2nd and 3rd
trimester of pregnancy (both primigravida and multigravida).
4 Patients who are willing to sign consent form and participate
in clinical trial.

 
 
ExclusionCriteria 
Details  1 Age less than 21 and more than 35 years.
2 Patients of 1st trimester of pregnancy.
3 Patients who are not fulfilling the inclusion
criteria.
4 Patients with Haemoglobin less than 8gm%.
5 Vibandha caused due to any medical and surgical
condition.
6 Patient with PIH (Pregnancy induced
hypertension)and GDM (Gestational Diabetes
Mellitus) and High-risk pregnancies (Molar
pregnancy and Ectopic pregnancy).  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Trial drug will help in management of constipation during pregnancy

 
follow up on 3rd day 7th day 15th day and 21st day

 
 
Secondary Outcome  
Outcome  TimePoints 
Trial drug will help to manage other associated symptoms   follow up on 3rd day 7th day 15th day & 21st day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Vibandha is not described as a separate disease in our Samhitas. It is described under symptoms of many diseases like Ajeerna, Samadosha, Koshthaashrita vata, Gudagata vata, Pakwasyagata vata.

The term Vibandha is mentioned with different context to Pureesha like Malasanga, Viddgraha, Vishtambha, Malabadhata, Stabhapureeshata. It occurs due to Vikruti of Apana vata and the Srotas involved is Pureeshavaha Srotas.

Gastrointestinal disorders are frequently experienced during pregnancy. As far as gastrointestinal complaints go, constipation is the most frequent, second after to nausea. During pregnancy upto 40% of women experience constipation symptoms at some point.

The word Constipation comes from Latin word ‘Constipare’ which means – To press or crowd together. It refers to persistent,difficult, infrequent or seemingly incomplete defecation.

It is defined as infrequent passage of hard stool. Patient may also complain of straining, a sensation of incomplete evacuation and either perineal or abdominal discomfort.

 It is a symptom, not an illness.

Constipation is quite common ailment during Pregnancy. Atonicity of the gut due to effect of Progesterone, diminished physical activity and pressure of the gravid uterus on the pelvic colon are the possible explanations. Emotional disturbances, Iron supplements, disturbed sleep are the other causes which leads to Constipation. Suppression of defecation urge is also a very important cause of Constipation.

It may cause backache and abdominal discomfort. Regular bowel movements may be facilitated by regulation of diet by taking plenty of fluids, vegetables and milk or prescribing stool softners at bed time. There may be rectal bleeding, painful fissures or haemorrhoids due to hard stool.


 
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